Last month, the council of ministers published its support of the
commission?s mid-term policy review of the EU?s life science and
biotechnology strategy. This stated that Europe must take advantage of
the technology by addressing the regulatory environment and improving
access to capital.
While describing this as an ?important step towards building the
bio-economy?, Europe?s biotech sector remains concerned that the
technology?s full potential will not be properly exploited until Europe
places science, and not public opinion, at the heart of its
decision-making process.

?According to the treaty of Rome, politicians have to take the
decisions,? says Europabio secretary general Johan Vanhemelrijck. ?EMEA
(European medicines agency) and EFSA (European food safety agency) were
set up to investigate and provide risk assessments on products, and then
politicians vote on the opinion. They tell us that their voting is
science based - it is ? but it is also influenced by public opinion.?

Europe, says Vanhemelrijck, is the only region in the world that
actually votes on the science. He argues that this is a major weakness -
politicians can vote positively or negatively on an opinion without
having to really justify their decision ? in contrast to other regions
of the world. Vanhemelrijck argues that outside influences have had a
significant impact on the fact that European politicians have
consistently voted against scientific evidence supporting the approval
of genetically modified (GM) products.

?If safety criteria for a product is fulfilled in the US, then it is
illegal for the authorities not to put the product on market,? says
Vanhemelrijck. ?So if I am an anti-GM pressure group, and I see that one
region votes on the science, while in another it would be illegal not to
put a product on the market if it meets the necessary safety criteria -
where would my efforts go? Where would I put fear? Where would I seed
doubt? Seeding a sense of doubt to cultivate a no vote would not help in
US. But it would in Europe.?

This situation, says Vanhemelrijck, has spiralled out of control. Once
authorisation is delayed, because politicians refuse to vote on positive
scientific results, suspicion is created within the public sphere that
there is a problem.

?This is despite the fact that 10 million farmers worldwide cultivate
100 million hectares. This is the total agricultural land of Europe.
Around 60 to 70 per cent of animals around the world have eaten GMOs.
There has been no documented case of harm to animal, human or
environmental health - and by documented I mean scientifically
documented. There has never in history been such a major technology
introduced on such a scale that has had no side effects like this one.?

Vanhemelrijck points out that problems of authorisation are almost
exclusively limited to products that end up in the food chain. European
politicians, he says, will happily vote in favour of biotech medicines
and veterinary products that receive positive scientific opinions, but
yield and growth enhancers in animal husbandry for example, will get a
negative vote after a positive scientific opinion.

?Why? Because it is not seen as being politically important to exploit
animals more than nature would allow you to. So we handicap the farmers,
who we pay anyway through subsidies. When it comes to GMOs, there is no
political gain for a lot of countries to vote in favour of a scientific
opinion.?

There are other instances where improvements at the European level could
enable the biotech sector to fulfil its potential. ?A good example is
clinical trials,? says Vanhemelrijck. ?In Europe there is a directive,
to which member states have added different elements. This means that,
as a company, if you want to conduct a clinical trial across several
countries, you will be confronted every time with a different set of
administrative burdens. You will therefore probably have to eliminate
some of these countries from your trials as you will want to preserve
the protocol of your trial, otherwise your trial will not be valid.?

The potential is there though. There are about the same number of
biotech companies in Europe as there are in the US ? though further
examination reveals that EU companies typically employ around half of
those in US, and invest around a third of their US counterparts in R&D.
In addition, they have access to about a sixth of the capital available
to American biotech firms. But Vanhemelrijck claims that large
traditional companies are beginning to include biotechnology within
normal production processes, and that a new market is emerging whereby
pioneering SMEs are becoming service providers to major firms involved
in anything from enzymes to textiles.

?Biotechnology is here,? says Vanhemelrijck. ?It is a political fact
that politicians can no longer deny. The overall feeling for biotech -
except for GM - is positive.

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